Senior Human Factors Engineer - Medical Devices (Hybrid)

Olympus Corporation; Boston (MA); Hybrid; USD 100,000 - 135,000; Full time

Benefits offered by this job

Competitive salary and bonus

401(k) with company match

Medical, dental, vision coverage

Paid time off and holidays

Job summary

Olympus Corporation in Westborough, MA is seeking a Senior Level Human Factors Engineer to lead Human Factors and Usability activities ensuring safety and regulatory compliance for medical devices. You will guide user-centered design from ideation through development, collaborating with design, regulatory, and clinical teams in a hybrid work setting.

The role requires extensive HF expertise, medical device experience, and strong leadership to mentor team members while advancing product usability

Qualifications

• Bachelor’s degree in HF, Cognitive Psychology, or related field.
• Minimum 5 years HF experience with BS or 4 years with MS.
• Medical device experience.
• Strong prioritization and multitasking.
• Knowledge of FDA, IEC, AAMI/ANSI requirements.

Responsibilities

• Act as HF subject matter expert providing technical leadership for product development and sustaining efforts.
• Lead multiple HF activities and ensure project execution and quality across sites.
• Provide expert HF input for design requirements for physical and digital devices, labeling and instructions.
• Generate HF documentation compliant with FDA, IEC 62366 and internal SOPs.
• Ensure HF deliverables reflect user needs and system safety considerations.
• Develop comprehensive HF/UE reports and risk analyses and support Design Validation as needed.
• Communicate HF strategies to Core Team and leadership with high quality deliverables.
• Mentor team members and vendors in HF practices and processes.
• Coordinate with Marketing and clinicians to understand procedures and environment for design decisions.
• Travel as needed up to 15% and collaborate across global teams.

Skills

Human Factors

Regulatory compliance

Risk analysis

Design Controls

Technical communication

Education

Bachelor’s degree in HF or related field

Master’s degree in HF or related

Job description

Olympus Corporation in Westborough, MA is seeking a Senior Level Human Factors Engineer to lead Human Factors and Usability activities ensuring safety and regulatory compliance for medical devices. You will guide user-centered design from ideation through development, collaborating with design, regulatory, and clinical teams in a hybrid work setting.

The role requires extensive HF expertise, medical device experience, and strong leadership to mentor team members while advancing product usability